Neonatal Bilirubin External Quality Assessment
Neonatal Bilirubin External Quality Assessment
The RIQAS Neonatal Bilirubin EQA programme has been designed to assess the performance of total and direct bilirubin assays with levels tailored to neonatal bilirubin testing.
- Lyophilised for enhanced stability
- Monthly reporting
- Human based serum
- Submit results and view reports online via RIQAS.net
- Rapid turnaround of reports allows for any necessary corrective actions to be taken with minimal disruption to laboratory output
Not accredited to ISO/IEC 17043
| Cat No | Kit Size | Frequency | Cycle Start | Parameters | |
|---|---|---|---|---|---|
| RQ9191 | 2 x (6x3ml) | Monthly | July | 2 | |
Parameter
- Direct Bilirubin
- Total Bilirubin
Please note, product availability may vary country to country.
RIQAS EQA Pilot Programmes
RIQAS is the world’s largest External Quality Assessment scheme with more than 50,000 laboratory participants spanning over 139 countries
RIQAS Pilot Programmes
We currently have no Pilot Programmes available.
Keep checking back for Pilots launching soon.
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RIQAS Brochure
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Randox International Quality Assessment Scheme (RIQAS)
RIQAS is the world’s largest External Quality Assessment scheme with more than 50,000 laboratory participants spanning over 139 countries
Key Benefits of RIQAS
Cost Effective
Consolidate EQA analysis, reduce workload and costs with our comprehensive, multi-parameter programmes.
Flexible Programme Options
Flexible programme options are available to suit all laboratory budgets. The option to register up to five instruments per programme (volume permitting) at no extra cost for comparative performance assessment
Highly Accredited
RIQAS programmes are accepted by national and international accreditation bodies including ISO 17043:2010 – “Conformity Assessment – General Requirements for Proficiency Testing”.
Expansive Peer Group Database
The availability of large peer groups ensures robust data is available for a wide range of instruments and methods.
Rapid, User-Friendly Reports
Our rapid, user-friendly reports allow at-a-glance performance assessment. Complimentary multi-instrument, inter-laboratory and end-of-cycle reports are also available.
Commutable Samples
A commutable sample matrix increases confidence that performance mimics that of patient samples.
Early Identification of Test System Errors
Frequent reporting allows early identification of test system errors, while our 72 hour report turnaround enables corrective action to be taken with minimum disruption to the lab.
Convenient Cloud Based Data System
RIQAS.net is a convenient, cloud based data entry system which allows participants to return results and view reports online.
Highest Quality Samples with Multi-Level Capabilities
EQA samples are manufactured to the highest quality standard and span clinically relevant levels.
RIQAS EQA Programmes
Choice & flexibility are guaranteed with our 35 programme portfolio.
Browse the programmes below
RIQAS EQA Reports
User-friendly, one-page per parameter reports allow for at-a-glance performance assessment.
Browse the reports below.
What Does RIQAS Provide?
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RIQAS Point of Care EQA
Designed to improve the quality of Point of Care Testing (POCT) in locations such as pharmacies, GP surgeries, hospital out patient departments, sports clinics, supermarkets, diagnostic/treatment and walk-in centres, RIQAS Point of Care EQA provides independent evidence of the accuracy and reliability of test results. Randox International Quality Assessment Scheme (RIQAS) is the world’s largest EQA scheme with over 47,000 participants in more than 139 countries.
Why RIQAS Point of Care?
About RIQAS Point of Care
How it Works
On a monthly basis we will distribute an identical sample of blood to all participating sites. Each participating site will test the sample in the same way they would test a real patient sample, then return their test results to RIQAS within a set time. The scheme is unique in distributing whole blood samples rather than serum based samples, this ensures that samples act identically to real patient samples at the point of care.
An electronic report is then sent to participants, comparing their results with other participants using the same analyser. Satisfactory and unsatisfactory performance is represented using a traffic light system, allowing instant identification of any issues. A more detailed breakdown of performance may be obtained if further information is required. With time, an overall picture will emerge showing whether results are consistently accurate and reliable or whether there may be an underlying analyser and/or operator issue.
Tests and Analysers
Test Role HbA1c • Diagnosing diabetes mellitus
• Monitoring treatment
• Encouraging self-managementTotal Cholesterol & HDL Cholesterol • Risk factors for heart disease
• Monitoring lipid lowering therapyC-Reactive Protein (CRP) • Early detection of infectious disease
• Identifying need for antibiotic treatmentGlucose • Diagnose and monitor diabetes
• Monitor for the presence of hypoglycaemia
(low blood glucose) and hyperglycaemia (high blood glucose)International Normalised Ratio (INR) • Used to measure the effect of anticoagulant
drugs such as warfarin
• Help diagnose a bleeding disorder; to help
estimate the severity of liver diseaseKetones • To determine whether excessive ketones are
present in the blood, to detect diabetic
ketoacidosis (DKA)Note – The RIQAS Point of Care range is constantly expanding to include new tests and analysers. Please contact us if your desired analyser or test is not currently displayed.Ordering Information
Panel Catalogue Number Lipids RQ9181/A Lipids + 1 panel RQ9181/B Lipids + 2 panels RQ9181/C Additional Sample RQ9181/D What Participants Say
Our unrivalled commitment to quality and service ensures high levels of customer satisfaction, this is evident from the responses to our latest customer satisfaction survey:
“All in all a quick and efficient service”
“Good online system”
“Very helpful team”
“Excellent training”
“They are an experienced team”
“Very satisfied with the service that we receive”
“Very good value for money”
“The website is great”Distribution Dates
Distribution Month Sample Distributed Result Submission Deadline January 2021 11th January 20th January February 2021 1st February 10th February March 2021 1st March 10th March April 2021 5th April 14th April May 2021 3rd May 12th May June 2021 7th June 16th June July 2021 5th July 14th July August 2021 2nd August 11th August September 2021 6th September 15th September October 2021 4th October 13th October November 2021 1st November 10th November December 2021 6th December 15th December Importance of Quality Assurance
Quality assurance is an essential aspect of any clinical/diagnostic testing service and is aimed at ensuring the accuracy and reliability of patients’ results. The right result allows the right clinical advice to be offered in a timely manner. Quality assurance operates at two levels:Internal Quality Control
Internal Quality Control includes operator training/ competency assessment, analyser/ test system maintenance, and adherence to policies/ processes. Whilst some point of care analysers include inbuilt quality checks, cross-check analysis against samples with known levels provides immediate assurance and evidence that a patient’s result is safe to report.External Quality Assessment
External Quality Assessment involves analysis of samples with unknown levels that have been distributed by an external organisation. Participants are informed how their results compare with other participants, hence providing independent evidence of performance. Increasingly, participation in an external quality assessment scheme is becoming a mandatory requirement where health and healthcare services are being provided.
EQA provides assurance to both staff and customers that testing provides accurate and reliable results.Want to know more?
Visit our Importance of EQA page to learn more.
Want to know more?
Contact us or download the RIQAS Point of Care catalogue to learn more.
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Frequently Asked Questions
RIQAS
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RIQAS Past Panels
RIQAS (Randox International Quality Assessment Scheme) is the largest global EQA scheme with over 50,000 participants in more than 139 countries. Our range currently comprises 33 programmes and the majority of clinical testing.
What are RIQAS Past Panels?
Available Panels
• Ammonia/ Ethanol
• Anti-TSH Receptor
• Blood Gas
• BNP
• Cardiac
• Cerebrospinal Fluid (CSF)
• Clinical Chemistry
• Coagulation
• CO-Oximetry
• CYFRA 21-1
• ESR
• Glycated Haemoglobin (HbA1c)
• Haematology
• Human Urine
• Immunoassay
• Immunoassay Speciality 1
• Immunoassay Speciality 2
• Immunosuppressant Drugs
• Lipid
• Liquid Cardiac
• Maternal Screening
• Serology Epstein Barr Virus (EBV)
• Serology (HIV/ Hepatitis)
• Serology (Syphilis)
• Serology (ToRCH)
• Specific Proteins
• Sweat Testing
• Therapeutic Drugs
• Trace Elements in Blood
• Trace Elements in Serum
• Trace Elements in Urine
• Urinalysis
• Urine Toxicology
*Product availability is dependent on RIQAS stock surplus levels.
Benefits of RIQAS Past Panels
All RIQAS Past Panels are provided with an Excel document containing supporting data for the instrument and method of interest.
RIQAS Past Panel samples span multiple levels, making them ideal for ensuring accurate instrument performance across the measuring range.
RIQAS Past Panels allow laboratories to receive comprehensive external QC reports even after program close.
Protected: QCMD – Molecular External Quality Control (NEW)
Infection: Making Sure You Get the Right Treatment
When you have an infection, it’s important to receive the correct diagnosis in order to access appropriate treatments. Misdiagnosis can not only lead to the prolonging of the infection, but could also prove detrimental to your long-term health, such as if you become resistant to certain anti-biotic strains through mistaken prescription.
Throughout this month, we’ve been highlighting how the Randox clinical product range can assess the impact of infection. The RX series’ dedicated testing panel comprises of IgA, hsCRP and ASO which are also available for third-party use. The extensive QC range caters for assessment of infectious disease testing in both liquid and lyophilised formats.
Reagents
The Randox range of third-party reagents enables the clinical analysis of 113 different analytes with comprehensive range measurements and excellent correlations to reference methods.
IgG (the most abundant antibody) and IgM (the first antibody made in response to infection) can be used in the diagnosis of Dengue Fever. This is significant as more than 40 % of the global population, in more than 100 countries, are at risk of the Dengue Virus.
IgA is an antibody that lines the mucous membranes lining the mouth, airways and digestive tract. A deficiency in IgA is common in patients with bronchitis, conjunctivitis and otitis media.
Other Randox assays that may be used to detect differing infections include: albumin, ferritin, alpha-1-antitrypsin (AAT), complement C3, complement C4, haptoglobin, CRP, alpha-1-acid glycoprotein (AGP) and anti-streptolysin (ASO).
RX series
The RX series range offers the most comprehensive testing profile for assessing infectious diseases within an individual. The RX series test menu possesses the most extensive infectious disease testing panel available to give an expansive picture of an individual’s health. The RX series zinc test will assess the levels of zinc in an individual, Zinc plays a significant role in an individual’s health s it’s functions include cell and enzyme production as well as wound healing.
To view the full RX series test menu click here.
Internal Quality Control
Randox has partnered with Qnostics to provide a wide range of molecular controls for infectious disease testing. Designed to meet the demand of today’s molecular diagnostics laboratory and laboratories carrying out Nucleic Acid Testing (NAT), the Qnostics Molecular Infectious Disease range comprises hundreds of characterised viral, bacterial and fungal targets covering a wide range of Transplant Associated Diseases, Respiratory Infections, Blood Borne Viruses, Sexually Transmitted Infections, Gastrointestinal Diseases and Central Nervous System Diseases.
External Quality Control
Randox have also partnered up with QCMD to offer a vast array of molecular EQA programmes for infectious disease testing. With an extensive database of over 2000 participants in over 100 countries, QCMD is one of the largest providers of molecular EQA in the field of molecular diagnostics.
Frequent challenges, comprehensive reports and international accreditation ensures the best assessment of test system performance.
For more information on how Randox is helping to diagnose infection accurately and effectively, visit www.randox.com.
September focus: Infection
Throughout the month of September, we will be highlighting on our social media channels how the Randox clinical range can help combat infections and infectious diseases through accurate and swift diagnosis, allowing the necessary steps to be taken in order to improve individual health.
What is infection?
Infection is the infiltration of an organism’s body tissues by disease-causing agents, their multiplication, and the reaction of host tissues to the infectious agents and toxins they produce. Infectious disease can also be known as communicable disease and transmissible disease.
How is the Randox helping to diagnose infection?
The Randox portfolio comprises of a wide range of products to combat infections including the RX series’ dedicated infectious disease testing panel, diagnostic reagents such as copper, potassium and sTfR and an extensive QC range catering for infectious disease testing in both liquid and lyophilised formats.
How can I limit my risk of contracting infection?
- The most important way to reduce the spread of infection is to wash your hands regularly with soap and water
- If you have an infection, get the appropriate vaccine and do not take antibiotics when they are not needed. This will only increase antibiotic-resistance
- Stay at home if you are sick to limit the spread of infection
- Use single-use tissues and dispose of them immediately after use
- Do not share cups, glasses or cutlery
- Do not touch your eyes, nose or mouth as viruses can transfer from your hands and in to the body
How can my workplace limit the spread of infection?
- Have an infection control plan
- Provide clean hand washing facilities
- Offer alcohol-based hand sanitisers when regular facilities are not available
- Provide boxes of single-use tissues and encourage their use
- Remind staff not to share cups, glasses or cutlery
- Remove newspapers and magazines from waiting areas
- Encourage staff to regularly disinfect their workspaces
- Make sure ventilation systems are working properly
For more information on how Randox is helping to diagnose infection, visit www.randox.com/infections.
Point of Care Testing (POCT) Explained
Point of Care Testing (POCT) is the delivery of a test at the point in time at which the result will be used to make a decision and taking appropriate action resulting in an improved health outcome. It is also known as near patient, bed-side, extra-laboratory, decentralised, and ancillary testing [1]. It has been shown to reduce hospital stay time, reduce complications, and improve adherence to treatment [2].
Point of care testing is not a recent practice; many early diagnostic tests were administered at the bedside. However, analytical technology has progressed and multiple tests can be performed within minutes in a laboratory. Recently, this technology has been put into the hands of the staff near the patients [2]. There are two types of technology, benchtop analysers and hand held devices. Bench top systems are just smaller versions of laboratory analysers but some steps are automated. Hand held devices are simple in appearance but complex internally, they can manage several tasks including, adding reagents, separating cells from plasma, and reading colour or other measures.
Results can be obtained faster, allowing for more immediate decisions meaning treatment can begin sooner. Patients can live a longer and higher quality life, helped by a reduction in the length of hospital stays.
Some benefits of POCT [2]:
Key objective
The main objective of Point of Care Testing is to generate results more quickly so that appropriate treatment can be provided, resulting in an improved patient outcome.
Management
Accurate and reliable results can only be obtained if the patient and sample are treated correctly. Point of care testing is likely to be performed by staff with a limited technical background, so training and quality control are vital.
Outcomes
Proper analysis technique alone is not enough to ensure an accurate decision; any test will only be beneficial if the appropriate action is taken based on the result. The effectiveness of POCT is assessed in terms of the overall outcome of the patient.
There are three phases in the POCT cycle: pre-analytical phase, analytical phase, and post-analytical phase. About 90% of quality issues are attributed to the pre-analytical and post-analytical phases [3]. These errors are mainly attributed to user error and can be caused by a number of issues including, selecting the wrong POCT device, not following manufacturer instructions, inadequate training, not adhering to appropriate QC practices, and many more.
The errors can usually be mitigated by implementing an action plan and ensuring it is executed exactly as designed, deviation from the action plan will lead to errors. Errors in POCT diagnostics can lead to misdiagnosis, improper treatment, costly follow-up procedures, and death.
Some strategies for improvement:
Internal Quality Control and External Quality Assessment is conducted to monitor the stability of the analytical measurement system and to alert the operator to a change that may lead to a medically significant error [6].
A study by Price, Smith and Bruel [8] was conducted on a number of labs over a period of time of up to 15 years. They discovered that test result performance improved with time and was associated with regular participation in External Quality Assessment (EQA) schemes and with the use of internal quality control (IQC) procedures.
Internal Quality Control
Internal Quality Control (IQC) is used to assess the day-to-day consistency of assay performance, providing quality assurance for patient results. IQC activities are among the ten most common POCT deficiencies. These may include performing and documenting quality control testing and taking the correct action for outliers [4]. This poor performance could be attributed to how IQC is viewed in POCT; users may lack appreciation of the potential for errors and may see the analyser as infallible, they likely see IQC as an additional workload as opposed to part of their testing routine.
CLSI regulations require risk assessment for each stage of patient testing alongside an implementation of a quality control plan. Below are some suggestions for how IQC should be conducted for POCT.
Conduct
IQC should be conducted when: a new lot of consumable is used; a patient result is queried; after maintenance; the device has been physically insulted. IQC should be conducted by the usual device operator so assurance can be provided for the whole testing process.
Training
ISO 22870 requires POCT users should be trained in the theory and practice of IQC [5]. Staff should be trained in every aspect of POCT including storage, preparation, frequency, documentation and basic troubleshooting.
Material
QC material for POCT should be obtained from a third party provider and not rely on material provided by the device manufacturer, the benefits of which are well documented. It should also contain analytes at clinically relevant concentrations, be provided ready-to-use, and be stable at ambient temperatures.
Results
All IQC results must be recorded with the date, time, user, decision to accept or reject, and any actions taken as appropriate. Locally assigned ranges alongside analyte-specific rules should be used to maximise error detection. An example of how IQC could be recorded and an action flowchart can be seen in Fig. A below.
Troubleshooting
There should be a protocol for required actions following a failed IQC. Any troubleshooting should be developed with knowledge of the most common errors and user capability.
Review
A monthly review should be conducted to identify persistent failures and trends.
The cost of IQC may also be a factor in resistance to IQC, however, while it is difficult to quantify, the cost of not conducting it may be greater in terms of human harm. A whitepaper is available detailing IQC in POCT (download).
![Fig. A Examples of a manual IQC documentation, adapted from the Australian Government’s POCT General Practice [4]](https://www.randox.com/wp-content/uploads/2018/08/Fig.-A.jpg)
Fig. A Examples of a manual IQC documentation, adapted from the Australian Government’s POCT General Practice [4]. (Click to expand)
External Quality Assessment
External Quality Assessment (EQA) or Proficiency Testing (PT) involves running blind patient-like samples and comparing your results to peer results, in order to retrospectively monitor the accuracy of reporting. EQA samples should be treated as if they were a patient sample and therefore must be run by personnel who would normally use the device. This provides confidence in the reliability of patient test results. (Learn more about EQA)
Benefits of participation in an EQA programme include assessment of result accuracy, assessment over time, comparisons with instruments, methods and peers, and providing confidence in test results.
EQA for POCT is, in theory, similar to EQA in a large laboratory. There is a significant difference however, the POCT participants are usually health care professionals with little knowledge of laboratory medicine. A lack of understanding of the importance of EQA had led to a smaller percentage of sites participating than large laboratories.
A Good EQA Scheme
A good EQA scheme should offer:
Conducting EQA in POCT
Below are some suggestions for how EQA should be conducted for POCT.
Conduct
EQA should be conducted by the operator who normally conducts patient testing to ensure the true workflow is assessed [6].
Material
EQA samples should be commutable, meaning they have the same numeric relationship between measurements procedures as is observed for a panel of patient samples (reacts the same as a real patient sample).
Report Frequency
Challenges / surveys should be frequent enough to identify systematic errors in a timely manner, affecting the fewest patient results [10].
Report Turnaround
A fast turnaround time allows test system errors to be identified sooner and necessary corrective actions to be taken immediately with minimum disruption to the lab.
Review
A regular review of past EQA results should be part of the cycle of quality.
Guidance
A POCT EQA provider should be able to provide assistance when the user is having difficulties.
Results
Individuals carrying out testing should have the correct knowledge to interpret results, choosing a scheme with easy to interpret results can help.
Internal Quality Control
Randox offer a number of controls suitable for Point of Care Testing applications:
Acusera Blood Gas Control
The Randox Acusera Blood Gas Quality Controls contain assayed target values for ten parameters, covering pH, pCO2, pO2, electrolytes, glucose and lactate. The material is provided in easy to open ampoules for added convenience and ease-of-use. The liquid ready-to-use nature of the control makes it ideal for use in point-of-care testing and on a wide range of blood gas instruments.
Acusera Liquid Cardiac Control
The Randox Acusera Liquid Cardiac control is designed to be both convenient and easy to use. The liquid ready-to-use format makes it ideal for both clinical laboratories and point-of-care testing. Assayed, instrument specific values are provided for an impressive 8 cardiac markers including, NT-ProBNP, D-dimer and Troponin ensuring consolidation and flexibility. Furthermore, an open vial stability of 30 days for all analytes helps to keep waste and costs to a minimum.
Acusera Liquid HbA1c Control
Liquid Urine Control
The Randox Acusera Liquid Urine quality control is designed to be both convenient and easy to use. The liquid ready-to-use format eliminates issues with pipetting and allows convenient storage at 2℃ – 8℃. Assayed instrument and method specific target values and ranges are provided for 18 commonly tested urine chemistry parameters.
External Quality Assessment
Randox offers RIQAS Point of Care, a simple EQA scheme designed for use in point of care settings. It is a single sample, single scheme programme featuring whole blood samples for authentic patient sample assessment.
RIQAS
RIQAS Point of Care
Acusera
[1] C. Price, A. St john and J. Hicks, “Point-of-care testing”, 2004. [Online]. Available: http://mldt.hu/upload/labor/document/PRICEP.pdf. [Accessed: 23- Jul- 2018].
[2] C. Price, “Point of care testing”, BMJ, vol. 322, pp. 1285-1288, 2001.
[3] A. Okorodudu, “Optimizing accuracy and precision for point-of-care tests”, Acutecaretesting.org, 2011. [Online]. Available: https://acutecaretesting.org/en/articles/optimizing-accuracy-and-precision-for-point-of-care-tests. [Accessed: 24- Jul- 2018].
[4] H. Holt and D. Freedman, “Internal quality control in point-of-care testing: where’s the evidence?”, Annals of Clinical Biochemistry, vol. 53, no. 2, pp. 233-239, 2016.
[5] “ISO 22870:2016 – Point-of-care testing (POCT) — Requirements for quality and competence”, Iso.org, 2018. [Online]. Available: https://www.iso.org/standard/71119.html. [Accessed: 25- Jul- 2018].
[6] J. Gill and M. Shephard, “The Conduct of Quality Control and Quality Assurance Testing for PoCT Outside the Laboratory”, Clin Biochem Rev., vol. 31, no. 3, pp. 85-88, 2010.
[7] A. Stavelin and S. Sandberg, “Essential aspects of external quality assurance for point-of-care testing”, Biochemia Medica, pp. 81-85, 2017.
[8] C. Price, I. Smith and A. Van den Bruel, “Improving the quality of point-of-care testing”, Family Practice, vol. 35, no. 4, pp. 358-364, 2017.
[9] “ISO 15189:2012 – Medical laboratories — Requirements for quality and competence”, Iso.org, 2018. [Online]. Available: https://www.iso.org/standard/56115.html. [Accessed: 31- Jul- 2018].
[10] J. Crilly, “Mythbusting: Frequency of EQA Reports”, Randox Laboratories, 2017.
[11] G. Kristensen and P. Meijer, “Interpretation of EQA results and EQA-based trouble shooting”, Biochemia Medica, pp. 49-62, 2017.
Nutritional status: copper deficiency
Did you know that copper is an essential trace mineral present in all tissues? It works with iron to help the body form red blood cells. It also helps keep the blood vessels, nerves, immune system and bones healthy while also aiding in iron absorption. In rare situations, copper deficiency can occur and lead to anaemia and osteoporosis.
Symptoms of copper deficiency include:
- Fatigue & weakness as cells use copper to generate ATP, the body’s main source of energy. This means that copper deficiency could affect your energy levels.
- Frequent sickness as copper plays an important role in maintaining a healthy immune system.
- Weak and brittle bones as copper is involved in the processes that create cross-links inside your bones. These cross-links ensure bones are healthy and strong.
- Problems with memory and learning as copper plays an important role in brain function and development.
Sensitivity to cold as copper, along with minerals like zinc, help maintain optimal thyroid gland function. Low thyroid levels can make you feel colder more easily.
There are many foods that are high in copper. These include leafy greens, including turnip, greens, spinach, kale and mustard greens. Asparagus and summer squash are two other excellent sources of copper while legumes, whole grains, nuts and seeds are also good sources of the substance.
Randox Reagents, RX and QC are helping to diagnose copper deficiency at the earliest possible stage. The Randox copper assay is used to measure the levels of copper in the blood in order to determine copper toxicity. Combining this with the Randox zinc assay can aid in identifying the cause of liver damage in a patient, leading to correct treatment and recovery.
Find out more about how Randox is helping to diagnose nutritional status and deficiencies here: https://www.randox.com/nutritional-status/
